Cleanroom environments are used throughout an array of industries to ensure a limited number of particulates are present in critical processes. These controlled environments limit pollutants and typically maintain specific airflow, pressure, temperature, relative humidity, & particle count levels. Most cleanrooms are found in manufacturing and scientific research and are designed to meet the needs of the process. Cleanrooms are often regulated by government bodies and require consistent tracking and recording of environmental parameters
Pharmaceutical cleanrooms are used in both manufacturing and research. These cleanrooms are subject to government regulation and must meet specific requirement such as cGMP, EU GMP and electronic record keeping (21 CFR Part 11) to ensure compliance
Medical Device cleanrooms typically operate under ISO 14644 standards as ISO 5-8 environments. Automated particle counting is commonly used to maximize product quality. These cleanrooms are used for both device manufacturing and the associated packaging.
Compounding Pharmacies are designed to comply with USP 797 & 800 requirements. These environments are typically ISO 7 rooms with internal laboratory fume hoods. Temperature and pressure must be maintained and monitored in order to remain compliant.
Electronic assembly cleanrooms have tight control over environmental parameters, especially particle count levels. Contaminents such as dust and fiberous materials can result in poor product yield and costly losses. Many manufacturers use handheld or automated remote particle counters to ensure proper levels